Supreme Court rules on generic drug liability

Open up your medicine cabinet. Do you have any generic drugs, or are all your medicines name-brand labels? Chances are, you’ve gone the cheaper route with generic drugs at least once.

If this is the case, you need to pay to attention to the latest groundbreaking legal and pharmaceutical development from Washington, D.C.:

In a historic decision that could forever affect the safety and regulation of the pharmaceutical industry in the United States, the Supreme Court recently ruled that generic drug manufacturers could not be sued by patients claiming that drugs they took were defectively designed.

According to an article from The New York Times, the 5-to-4 decision of the Supreme Court overturned the verdict of a New Hampshire jury. In 2010, the jury awarded $21 million to a woman who developed a debilitating skin disease after using a generic version of sulindac, a pain medication.

Because the drug’s manufacturer, Mutual Pharmaceutical Company, was required by federal law to make a copy of the name-brand medication Clinoril, it could not be held at all responsible for any claims that the drug was in any way unsafe.

Generic drug manufacturers are thrilled by the decision, arguing that the decisions of a state court should not override the authority of the Food and Drug Administration, which approves generic copies of brand-name drugs.

Not all the justices agreed with the majority, however. Justice Sonia Sotamayor stated in the dissenting opinion:

“Manufacturers regularly take drugs off the market when evidence emerges about a drug’s risks, particularly when safer drugs that provide the same therapeutic benefits are available.”

Justice Sotamayor pointed out that it is still the responsibility of the manufacturer to produce a safe product, even after the approval of the FDA.

This is definitely a decision that will have resounding affects in the pharmaceutical and legal fields. If you have any questions about the ruling, or about product liability in general, feel free to contact us.